Dataset Information

Sustained Care Smoking Cessation Intervention for Individuals Hospitalized for Psychiatric Disorders: The Helping HAND 3 Randomized Clinical Trial.

ABSTRACT:

Importance

Smoking among individuals with serious mental illness (SMI) represents a major public health problem. Intervening during a psychiatric hospital stay may provide an opportunity to aid engagement in smoking cessation treatment and facilitate success in quitting.

Objective

To examine the effectiveness of a multicomponent, sustained care (SusC) smoking cessation intervention in adults with SMI receiving inpatient psychiatric care.

Design, setting, and participants

The Helping HAND 3 randomized clinical trial compared SusC with usual care (UC) among individuals with SMI who smoked daily and were receiving inpatient psychiatric care in Austin, Texas, in a single hospital. The study was conducted from July 2015 through August 2019.

Interventions

The UC intervention involved brief smoking cessation information, self-help materials and advice from the admitting nurse, and an offer to provide nicotine replacement therapy during hospitalization. The SusC intervention included 4 main components designed to facilitate patient engagement with postdischarge smoking cessation resources: (1) inpatient motivational counseling; (2) free transdermal nicotine patches on discharge; (3) an offer of free postdischarge telephone quitline, text-based, and/or web-based smoking cessation counseling, and (4) postdischarge automated interactive voice response calls or text messages.

Main outcomes and measures

The primary outcome was biochemically verified 7-day point-prevalence abstinence at 6-month follow-up. A secondary outcome was self-reported smoking cessation treatment use at 1, 3, and 6 months after discharge.

Results

A total of 353 participants were randomized, of whom 342 were included in analyses (mean [SD] age, 35.8 [12.3] years; 268 White individuals [78.4%]; 280 non-Hispanic individuals [81.9%]; 169 women [49.4%]). They reported smoking a mean (SD) of 16.9 (10.4) cigarettes per day. Participants in the SusC group evidenced significantly higher 6-month follow-up point-prevalence abstinence rates than those in the UC group (8.9% vs 3.5%; adjusted odds ratio, 2.95 [95% CI, 1.24-6.99]; P = .01). The number needed to treat was 18.5 (95% CI, 9.6-306.4). A series of sensitivity analyses confirmed effectiveness. Finally, participants in the SusC group were significantly more likely to report using smoking cessation treatment over the 6 months postdischarge compared with participants in the UC group (74.6% vs 40.5%; relative risk, 1.8 [95% CI, 1.51-2.25]; P < .001).

Conclusions and relevance

The findings of this randomized clinical trial provide evidence for the effectiveness of a scalable, multicomponent intervention in promoting smoking cessation treatment use and smoking abstinence in individuals with SMI following hospital discharge.

Trial registration

ClinicalTrials.gov Identifier: NCT02204956.

SUBMITTER: Brown RA

PROVIDER: S-EPMC8100915 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

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Publications

Sustained Care Smoking Cessation Intervention for Individuals Hospitalized for Psychiatric Disorders: The Helping HAND 3 Randomized Clinical Trial.

Brown Richard A RA Minami Haruka H Hecht Jacki J Kahler Christopher W CW Price Lawrence H LH Kjome Kimberly L KL Bloom Erika Litvin EL Levy Douglas E DE Carpenter Kelly M KM Smith Ashleigh A Smits Jasper A J JAJ Rigotti Nancy A NA

JAMA psychiatry 20210801 8

<h4>Importance</h4>Smoking among individuals with serious mental illness (SMI) represents a major public health problem. Intervening during a psychiatric hospital stay may provide an opportunity to aid engagement in smoking cessation treatment and facilitate success in quitting.<h4>Objective</h4>To examine the effectiveness of a multicomponent, sustained care (SusC) smoking cessation intervention in adults with SMI receiving inpatient psychiatric care.<h4>Design, setting, and participants</h4>Th ...[more]

PMID: 33950156

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Project description:IntroductionHospitalization provides an opportunity for smokers to quit, but tobacco-cessation interventions started in hospital must continue after discharge to be effective. This study aimed to improve the scalability of a proven effective post-discharge intervention by incorporating referral to a telephone quitline, a nationally available cessation resource.Study designA three-site RCT compared Sustained Care, a post-discharge tobacco-cessation intervention, with Standard Care among hospitalized adult smokers who wanted to quit smoking and received in-hospital tobacco-cessation counseling.Setting/participantsA total of 1,357 daily smokers admitted to three hospitals were enrolled from December 2012 to July 2014.InterventionSustained Care started at discharge and included automated interactive voice response telephone calls and the patient's choice of cessation medication for 3 months. Each automated call advised cessation, supported medication adherence, and triaged smokers seeking additional counseling or medication support directly to a telephone quitline. Standard Care provided only medication and counseling recommendations at discharge.Main outcome measuresBiochemically confirmed past 7-day tobacco abstinence 6 months after discharge (primary outcome) and self-reported tobacco abstinence and tobacco-cessation treatment use at 1, 3, and 6 months and overall (0-6 months). Analyses were done in 2015-2016.ResultsSmokers offered Sustained Care (n=680), versus those offered Standard Care (n=677), did not have greater biochemically confirmed abstinence at 6 months (17% vs 16%, p=0.58). However, the Sustained Care group reported more tobacco-cessation counseling and medication use at each follow-up and higher rates of self-reported past 7-day tobacco abstinence at 1 month (43% vs 32%, p<0.0001) and 3 months (37% vs 30%, p=0.008). At 6 months, the difference narrowed (31% vs 27%, p=0.09). Overall, the intervention increased self-reported 7-day abstinence over the 6-month follow-up (relative risk, 1.25; 95% CI=1.10, 1.40; p=0.0006).ConclusionsA 3-month post-discharge smoking-cessation intervention for hospitalized smokers who wanted to quit did not increase confirmed tobacco abstinence at 6 months but did increase self-reported abstinence during the treatment period (3 months). Real-time linkage of interactive voice response calls to a quitline, done in this trial to increase scalability of a previously proven cessation intervention, demonstrated short-term promise but did not sustain long-term intervention effectiveness.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01714323.

Project description:ImportanceHealth care systems need effective models to manage chronic diseases like tobacco dependence across transitions in care. Hospitalizations provide opportunities for smokers to quit, but research suggests that hospital-delivered interventions are effective only if treatment continues after discharge.ObjectiveTo determine whether an intervention to sustain tobacco treatment after hospital discharge increases smoking cessation rates compared with standard care.Design, setting, and participantsA randomized clinical trial compared sustained care (a postdischarge tobacco cessation intervention) with standard care among 397 hospitalized daily smokers (mean age, 53 years; 48% were males; 81% were non-Hispanic whites) who wanted to quit smoking after discharge and received a tobacco dependence intervention in the hospital; 92% of eligible patients and 44% of screened patients enrolled. The study was conducted from August 2010 through November 2012 at Massachusetts General Hospital.InterventionsSustained care participants received automated interactive voice response telephone calls and their choice of free smoking cessation medication (any type approved by the US Food and Drug Administration) for up to 90 days. The automated telephone calls promoted cessation, provided medication management, and triaged smokers for additional counseling. Standard care participants received recommendations for postdischarge pharmacotherapy and counseling.Main outcomes and measuresThe primary outcome was biochemically confirmed past 7-day tobacco abstinence at 6-month follow-up after discharge from the hospital; secondary outcomes included self-reported tobacco abstinence.ResultsSmokers randomly assigned to sustained care (n = 198) used more counseling and more pharmacotherapy at each follow-up assessment than those assigned to standard care (n = 199). Biochemically validated 7-day tobacco abstinence at 6 months was higher with sustained care (26%) than with standard care (15%) (relative risk [RR], 1.71 [95% CI, 1.14-2.56], P = .009; number needed to treat, 9.4 [95% CI, 5.4-35.5]). Using multiple imputation for missing outcomes, the RR for 7-day tobacco abstinence was 1.55 (95% CI, 1.03-2.21; P = .04). Sustained care also resulted in higher self-reported continuous abstinence rates for 6 months after discharge (27% vs 16% for standard care; RR, 1.70 [95% CI, 1.15-2.51]; P = .007).Conclusions and relevanceAmong hospitalized adult smokers who wanted to quit smoking, a postdischarge intervention providing automated telephone calls and free medication resulted in higher rates of smoking cessation at 6 months compared with a standard recommendation to use counseling and medication after discharge. These findings, if replicated, suggest an approach to help achieve sustained smoking cessation after a hospital stay.Trial registrationclinicaltrials.gov Identifier: NCT01177176.

Project description:ImportanceSmoking cessation interventions for hospitalized patients must continue after discharge to improve long-term tobacco abstinence. How health systems can best deliver postdischarge tobacco treatment is uncertain.ObjectiveTo determine if health system-based tobacco cessation treatment after hospital discharge produces more long-term tobacco abstinence than referral to a community-based quitline.Design, setting, and participantsThis randomized clinical trial was conducted September 2018 to November 2020 in 3 hospitals in Massachusetts, Pennsylvania, and Tennessee. Cigarette smokers admitted to a study hospital who received brief in-hospital tobacco treatment and wanted to quit smoking were recruited for participation and randomized for postdischarge treatment to health system-based Transitional Tobacco Care Management (TTCM) or electronic referral to a community-based quitline (QL). Both multicomponent interventions offered smoking cessation counseling and nicotine replacement therapy (NRT) for up to 3 months. Data were analyzed from February 1, 2021, to April 25, 2022.InterventionsTTCM provided 8 weeks of NRT at discharge and 7 automated calls with a hospital-based counselor call-back option. The QL intervention sent referrals from the hospital electronic health record to the state quitline, which offered 5 counseling calls and an NRT sample.Main outcomes and measuresThe main outcome was biochemically verified past 7-day tobacco abstinence at 6 months. Self-reported point-prevalence and continuous tobacco abstinence and tobacco treatment utilization were assessed 1, 3, and 6 months after discharge.ResultsA total of 1409 participants (mean [SD] age, 51.7 [12.6] years; 784 [55.6%] women; mean [SD] 16.4 [10.6] cigarettes/day) were recruited, including 706 randomized to TTCM and 703 randomized to QL. Participants were comparable at baseline, including 216 Black participants (15.3%), 82 Hispanic participants (5.8%), and 1089 White participants (77.3%). At 1 and 3 months after discharge, more TTCM participants than QL participants used cessation counseling (1 month: 245 participants [34.7%] vs 154 participants [21.9%]; 3 months: 248 participants [35.1%] vs 123 participants [17.5%]; P < .001) and pharmacotherapy (1 month: 455 participants [64.4%] vs 324 participants [46.1%]; 3 months: 367 participants [52.0%] vs 264 participants [37.6%]; P < .001). More TTCM than QL participants reported continuous abstinence for 3 months (RR, 1.30; 95% CI, 1.06-1.58) and point-prevalence abstinence at 1 month (RR, 1.22; 95% CI, 1.08-1.35) and 3 months (RR, 1.23; 95% CI, 1.09-1.37) but not at 6 months (RR, 1.14; 95% CI, 0.99-1.29). The primary outcome, biochemically verified point-prevalence abstinence at 6 months, was not statistically significantly different between groups (19.9% vs 16.9%; RR, 1.18; 95% CI, 0.92-1.50).Conclusions and relevanceIn this randomized clinical trial, biochemically verified tobacco abstinence rates were not significantly different between groups at the 6-month follow-up. However, the health system-based model was superior to the community-based quitline model throughout the 3 months of active treatment. A longer duration of postdischarge treatment may sustain the superiority of the health system-based model.Trial registrationClinicalTrials.gov Identifier: NCT03603496.

Project description:ImportanceAlthough many people report a desire to quit smoking, concerns about mental health worsening after quitting are often raised by clinicians and people who smoke.ObjectiveTo assess changes in mental health following smoking cessation using 3 confirmatory coprimary analytical approaches.Design, setting, and participantsThis cohort study was conducted using data from a large, randomized clinical trial, the Evaluating Adverse Events in a Global Smoking Cessation Study. Analytical approaches included multivariable Tobit regression, propensity score adjustment, and instrumental variable regressions conducted from August to October 2022. Missing data were imputed for sensitivity analysis. The trial occurred in 16 countries at 140 centers between 2011 and 2015. Only data from participants who completed the trial collected in the US were available for this secondary analysis. Participants included adults with or without a psychiatric disorder who smoked.ExposureSmoking abstinence between weeks 9 through 24.Main outcomes and measuresAnxiety and depression scores were measured using the Hospital Anxiety and Depression Scale at 24 weeks, where a lower score indicates better mental health (range, 0-21).ResultsOf the 4260 participants included (mean [SD] age, 46.5 [12.4] years; 2485 women [58.3%]; 3044 White individuals [71.5%]), 2359 (55.4%) had a history of mental illness. The mean (SD) baseline Hospital Anxiety and Depression Scale score was 4.25 (3.68) (median [IQR], 3 [1-6]) for anxiety and 2.44 (2.91) (median [IQR], 1 [0-4]) for depression. After adjustment for demographics and baseline variables, smoking cessation was associated with a decrease in scores for both anxiety (-0.40 point; 95% CI, -0.58 to -0.22 point) and depression (-0.47 point; 95% CI, -0.61 to -0.33 point) compared with continuing smoking. Similarly, propensity score-adjusted models indicated that smoking cessation was associated with reduced scores for anxiety (β = -0.32; 95% CI, -0.53 to -0.11) and depression (β = -0.42; 95% CI, -0.60 to -0.24). Instrumental variable analysis was underpowered, and estimates were imprecise. Findings were robust to planned sensitivity and subgroup analyses, with larger effect sizes in people with a history of mental illness.Conclusions and relevanceIn this cohort study of people with and without psychiatric disorders, smoking cessation, sustained for at least 15 weeks, was associated with improved mental health outcomes in observational analyses, but the instrumental variable analysis provided inconclusive evidence. Findings like these may reassure people who smoke and their clinicians that smoking cessation likely will not worsen and may improve mental health.

Project description:ObjectivesCue-reactivity is a critical step leading to the emergence of addictive psychology and the triggering of addictive behaviors within the framework of addiction theory and is considered a significant risk factor for addiction-related behaviors. However, the effect of cue-reactivity targeted smoking cessation intervention and the cue-reactivity paradigms used in the randomized controlled trials varies, which introduces more heterogeneity and makes a side-by-side comparison of cessation responses difficult. Therefore, the scoping review aims to integrate existing research and identify evidence gaps.MethodsWe searched databases in English (PubMed and Embase) and Chinese (CNKI and Wanfang) using terms synonymous with 'cue' and 'tobacco use disorder (TUD)' to April 2023, and via hand-searching and reference screening of included studies. Studies were included if they were randomized controlled trials taking cue-reactivity as an indicator for tobacco use disorder (TUD) defined by different kinds of criteria.ResultsData were extracted on each study's country, population, methods, timeframes, outcomes, cue-reactivity paradigms, and so on. Of the 2,944 literature were retrieved, 201 studies met the criteria and were selected for full-text screening. Finally, 67 pieces of literature were selected for inclusion and data extraction. The results mainly revealed that non-invasive brain stimulation and exercise therapy showed a trend of greater possibility in reducing subjective craving compared to the remaining therapies, despite variations in the number of research studies conducted in each category. And cue-reactivity paradigms vary in materials and mainly fall into two main categories: behaviorally induced craving paradigm or visually induced craving paradigm.ConclusionThe current studies are still inadequate in terms of comparability due to their heterogeneity, cue-reactivity can be conducted in the future by constructing a standard library of smoking cue materials. Causal analysis is suggested in order to adequately screen for causes of addiction persistence, and further explore the specific objective cue-reactivity-related indicators of TUD.

Project description:BackgroundDepression is common among adults who smoke cigarettes. Existing depression-specific cessation interventions have limited reach and are unlikely to improve smoking prevalence rates among this large subgroup of smokers.ObjectiveThis study aimed to determine whether a mobile app-based intervention tailored for depression paired with a mailed sample of nicotine replacement therapy (NRT) is efficacious for treating depression and promoting smoking cessation.MethodsA 2-arm nationwide remote randomized clinical trial was conducted in the United States. Adults (N=150) with elevated depressive symptoms (Patient Health Questionnaire-8≥10) who smoked were enrolled. The mobile app ("Goal2Quit") provided behavioral strategies for treating depression and quitting smoking based on Behavioral Activation Treatment for Depression. Goal2Quit participants also received a 2-week sample of combination NRT. Treatment as usual participants received a self-help booklet for quitting smoking that was not tailored for depression. Primary end points included Goal2Quit usability, change in depression (Beck Depression Inventory-II) across 12 weeks, and smoking cessation including reduction in cigarettes per day, incidence of 24-hour quit attempts, floating abstinence, and 7-day point prevalence abstinence (PPA).ResultsIn total, 150 participants were enrolled between June 25, 2020, and February 23, 2022, of which 80 were female (53.3%) and the mean age was 38.4 (SD 10.3) years. At baseline, participants on average reported moderate depressive symptoms and smoked a mean of 14.7 (SD 7.5) cigarettes per day. Goal2Quit usability was strong with a mean usability rating on the System Usability Scale of 78.5 (SD 16.9), with 70% scoring above the ≥68 cutoff for above-average usability. Retention data for app use were generally strong immediately following trial enrollment and declined in subsequent weeks. Those who received Goal2Quit and the NRT sample reported lower mean depressive symptoms over the trial duration as compared to treatment as usual (difference of mean 3.72, SE 1.37 points less; P=.01). Across time points, all cessation outcomes favored Goal2Quit. Regarding abstinence, Goal2Quit participants reported significantly higher rates of 7-day PPA at weeks 4 (11% vs 0%; P=.02), 8 (7-day PPA: 12% vs 0%; P=.02), and 12 (16% vs 2%; P=.02).ConclusionsA mobile app intervention tailored for depression paired with a sample of NRT was effective for depression treatment and smoking cessation. Findings support the utility of this intervention approach for addressing the currently unmet public health treatment need for tailored, scalable depression-specific cessation treatments.Trial registrationClinicalTrials.gov NCT03837379; https://clinicaltrials.gov/ct2/show/NCT03837379.

Project description:IntroductionIncreasing evidence suggests that a diagnosis of a respiratory health condition, such as COVID-19, can prompt a smoker to quit, providing an opportunity to promote and support smoking cessation. However, mandatory quarantine, because of a COVID-19 infection, may stimulate an increase in smoking, making such efforts seem inappropriate or ineffective. This study aimed to investigate the feasibility of a telephone-based smoking cessation intervention for smokers with COVID-19 in Malta.MethodsAn experimental design with a mixed-methods approach was adopted. Participants (n=80) were recruited from a COVID-19 testing center and equally randomized to the intervention (advised to quit and offered three or four telephone-based smoking cessation support sessions) and control (no intervention) groups. Both groups were asked about their smoking habits at baseline and at follow-up at 1 month and at 3 months. The participants in the intervention group were invited to provide feedback on the intervention using questionnaires and by holding interviews.ResultsParticipants were recruited at a rate of 74.1% between March and April 2022. Most participants were female (58.8%), with a mean age of 41.6 years who smoked about 13 cigarettes per day. The majority (75%) accepted the offered smoking cessation support, receiving an average of two to three sessions. Findings indicate that the participants were satisfied with the support, finding it useful for attempting to quit. More participants in the intervention group reported a serious quitting attempt and a 7-day point prevalence abstinence at any point during the first month. However, 7-day point prevalence abstinence rates did not differ at the follow-up at 3 months.ConclusionsThe study suggests that providing smoking cessation support to individuals with COVID-19 is feasible and well-received. However, the findings suggest that the intervention's impact may have been brief. Thus, further research is recommended before conducting a conclusive trial.

Project description:IntroductionAlthough e-cigarettes are not a federally approved tobacco cessation aid in the United States, many smokers use them to quit or cut down on smoking. Tailored behavioral support could improve rates of complete smoking cessation for those individuals.Aims and methodsA novel behavioral treatment to help dual cigarette and e-cigarette users quit smoking was tested in a randomized pilot with a state tobacco quitline. Ninety-six dual users of cigarettes and e-cigarettes were recruited from incoming state quitline callers and randomized to receive enhanced e-cigarette coaching (EEC) or quitline treatment as usual (TAU) to examine EEC feasibility and acceptability. Outcomes at 3 months were treatment satisfaction, engagement, beliefs, and smoking cessation. This pilot was not powered to detect differences in quit rates.ResultsSixty-nine percent responded to the 3-month survey. EEC treatment satisfaction was noninferior to TAU: 93.8% (30/32) of EEC and 73.5% (25/34) of TAU reported being "very satisfied" or "satisfied" with treatment, respectively. EEC participants completed more coaching calls than TAU (M = 3.4 vs. M = 2.7, p = .03), and the majority in both groups elected to receive nicotine replacement therapy (EEC: 100%, TAU: 94%, p = .24). With missing data imputed as smoking, intent-to-treat 7-day point prevalence smoking abstinence rates were 41.3% (19/46) for EEC and 28.0% (14/50) for TAU (p = .20).ConclusionsThe EEC quitline intervention for dual cigarette and e-cigarette users demonstrated high levels of treatment satisfaction and engagement. This pilot was not powered to detect significant differences in smoking cessation; however, cessation rates were promising and warrant evaluation in a fully powered trial.ImplicationsIf this scalable behavioral treatment to help dual cigarette and e-cigarette users quit smoking proves to be effective in a larger trial, quitlines could implement this harm reduction approach to improve outcomes for callers who already use e-cigarettes and are planning to use them while quitting smoking.

Dataset Information

Sustained Care Smoking Cessation Intervention for Individuals Hospitalized for Psychiatric Disorders: The Helping HAND 3 Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Sustained Care Smoking Cessation Intervention for Individuals Hospitalized for Psychiatric Disorders: The Helping HAND 3 Randomized Clinical Trial.

Similar Datasets

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